MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING; CATHETER, PERCUTANEOUS

Model Number	24716
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first day of the month of bsc aware date since event date not provided.
Event or Problem Description
It was reported that balloon pinch off occurred.A 7.0x220150-hybrid sterling balloon catheter was advanced for dilation.When the balloon was fully inflated to rated burst pressure, a waste was noted in the middle of the balloon.The device was then removed and inflated outside and it showed to be pinched off approximately in the mid part of the balloon.The procedure was completed with a new balloon.No patient complications nor injuries were reported.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10871730
• Report Number: 2134265-2020-15948
• Device Sequence Number: 11413322
• Product Code: LIT
• UDI-Device Identifier: 08714729845560
• UDI-Public: 08714729845560
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K132430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/16/2022
• Device Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0026031103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1